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Real-world treatment outcomes of carfilzomib plus dexamethasone in patients with relapsed and/or refractory multiple myeloma, focusing on the impact of trial-fitness: CAtholic REsearch network for Multiple Myeloma study (CAREMM-2203)

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Abstract

Introduction

Carfilzomib plus dexamethasone (Kd) is widely used in patients with relapsed and/or refractory multiple myeloma (RRMM). However, the treatment outcomes of Kd, especially in trial-unfit patients, have not been extensively studied in the real-world setting.

Methods

We analyzed the outcomes of 152 RRMM patients who received Kd at our hospitals from April 2018 to March 2022.

Results

At the commencement of Kd, patients received a median of two (range 1–7) lines of prior anti-myeloma therapy. According to the ENDEAVOR study criteria, 93 (61.2%) and 59 (38.8%) patients were classified as the trial-fit and the trial-unfit group, respectively. The overall response (OR) rate for the entire cohort was 71.1% (95% CI 63.2–78.1%). Progression-free survival (PFS) and overall survival (OS) were 5.6 months (95% CI 3.9–6.9 months) and 24.0 months (95% CI 13.4–38.0 months), respectively. There was no significant difference in the OR rate between the trial-fit and the trial-unfit groups (76.3% vs. 62.7%; P = 0.105). However, the median PFS (3.6 months vs. 7.3 months; P < 0.001) and OS (15.0 vs. 36.8 months; P = 0.009) were significantly shorter in the trial-unfit group. On multivariate analysis, trial-fitness (unfit vs. fit) remained a significant covariate influencing the TRM (HR: 4.84, 95% CI 1.66–14.06; P = 0.004) and PFS (HR: 1.82, 95% CI 1.27–2.62; P = 0.001).

Conclusion

Our data suggest that the treatment outcomes of Kd are acceptable in the real-world setting with significant differences between the trial-fit and the trial-unfit groups, although they are relatively inferior to those of a pivotal trial.

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Data availability

Data will be provided upon request to corresponding author (SH).

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Acknowledgements

This study was supported by the National R&D Program for Cancer Control through the National Cancer Center (NCC) funded by the Ministry of Health & Welfare, Republic of Korea (HA21C0013).

Funding

This work was not supported by any public or commercial funding.

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Author notes

  1. Sung-Soo Park and Seo-Young Goo contributed equally to this work.

  2. Seung-Hwan Shin and Chang-Ki Min contributed equally to this work.

Authors and Affiliations

  1. Hematology Hospital, Seoul St. Mary’s Hospital, The Catholic University of Korea, 222, Banpo-daero, Seocho-gu, Seoul, 06591, South Korea

    Sung-Soo Park, Seo-Young Goo & Chang-Ki Min

  2. Department of Hematology, Yeouido St. Mary’s Hospital, The Catholic University of Korea, Seoul, South Korea

    Young-Woo Jeon

  3. Department of Hematology, Incheon St. Mary’s Hospital, The Catholic University of Korea, Incheon, South Korea

    Seung-Ah Yhang

  4. Myeoma Center, Hematology Institute, Eunpyeong St. Mary’s Hospital, The Catholic University of Korea, 1021, Tongil-ro, Eunpyeong-gu, Seoul, 03312, South Korea

    Seung-Hwan Shin

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Contributions

Conception and design: S-HS and C-KM. Data collection: S-HS, S-SP, and S-YG. Analysis and interpretation of data: S-SP, S-YG, Y-WJ, S-AY and S-HS. Writing, review, and revision of the manuscript: S-SP, S-YG, and S-HS. Final approval of manuscript: all authors.

Corresponding authors

Correspondence to Seung-Hwan Shin or Chang-Ki Min.

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Conflict of interest

The authors declare no competing interests.

Institutional review board

This study was approved by the Central Institutional Review Board of the Catholic University of Korea (#XC22RIDI0077). It was conducted in accordance with the tenets of the Declaration of Helsinki.

Informed consent

Patients provided written informed consent to receive Kd with permission to use their data in future retrospective studies.

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Park, SS., Goo, SY., Jeon, YW. et al. Real-world treatment outcomes of carfilzomib plus dexamethasone in patients with relapsed and/or refractory multiple myeloma, focusing on the impact of trial-fitness: CAtholic REsearch network for Multiple Myeloma study (CAREMM-2203). J Cancer Res Clin Oncol 149, 16279–16291 (2023). https://doi.org/10.1007/s00432-023-05385-8

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